Recruiting

Pentoxifylline for Cocaine Use Disorder

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Placebo

+ Cocaine (IV)

+ Pentoxifylline

Drug
Who is being recruted

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledEarly Phase 1
Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorWilliam Stoops
Study ContactWilliam W Stoops, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 10, 2025

Actual date on which the first participant was enrolled.

This study aims to explore how a medication called pentoxifylline might affect people who use cocaine. Cocaine use disorder is a condition where individuals struggle to control their cocaine use, leading to various health and social problems. Researchers are interested in understanding if pentoxifylline, which is known to target inflammation in the body, can alter the effects of cocaine. This could potentially lead to new ways to help those with cocaine use disorder by reducing harmful effects or cravings associated with cocaine use. Participants in this study will receive pentoxifylline and then be observed in a controlled environment to see how it influences their response to cocaine. This involves monitoring various aspects, such as the body's reaction and any changes in behavior or cravings. By examining these responses, researchers hope to gather valuable data on the interaction between pentoxifylline and cocaine, paving the way for future treatments. The study is conducted carefully to ensure participants' safety while collecting essential information.

Official TitleTargeting Immune Inflammation in Cocaine Use Disorder: A Human Laboratory Study With Pentoxifylline
NCT07086794
Principal SponsorWilliam Stoops
Study ContactWilliam W Stoops, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: 1. able to speak/read English, 2. not seeking treatment for drug use at the time of the study, 3. female or male between the ages of 18 and 55 years, 4. recent smoked or intravenous cocaine use verified by benzoylecgonine positive urine, as well as fulfillment of DSM-5 diagnostic criteria for CUD, 5. judged to be medically and psychiatrically healthy by study physicians other than the diagnosis for CUD at the time of screening, 6. ECG, read by a cardiologist, within normal limits, 7. females using an effective form of birth control and not pregnant or breastfeeding and 8) no known contraindications or allergies to pentoxifylline. Exclusion Criteria: 1. unable to speak/read English, 2. seeking treatment for drug use, 3. under 18 years or over 55 years, 4. no recent smoked or intravenous cocaine use as indicated by benzoylecgonine negative urine and no DSM-5 diagnosis of CUD, 5. judged to be medically or psychiatrically unhealthy by study physicians at the time of screening, 6. ECG, read by a cardiologist, outside normal limits, 7. females not using an effective form of birth control or pregnant or breastfeeding, 8. contraindications or allergies to pentoxifylline, and 9. Self-reported history of head trauma, seizure, CNS tumors, or use of concomitant medications that lower seizure threshold, or first-degree family history of seizures.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Subjects will be treated daily with oral pentoxifylline (1200 mg).

Group II

Experimental
Subjects will be treated daily with oral pentoxifylline (1600 mg).

Group III

Placebo
Subjects will be treated daily with an oral placebo.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Psychopharmacology of Addiction Laboratory

Lexington, United StatesOpen Psychopharmacology of Addiction Laboratory in Google Maps
Recruiting
One Study Center